Laparoscopic Ovarian Cystectomy of Endometrioma vs Deroofing and Ovarian Reserve

Ain Shams University

Status: Completed

Conditions: Endometrioma

Treatments: Procedure: Laparoscopic ovarian cystectomy; Procedure: laparoscopic cyst deroofing

Study type: Interventional

Funder types: Other

Identifiers

NCT01808170

05081985

m120984 (Other Identifier)

Details and patient eligibility

About

The purpose of this study is to evaluate the impact of laparoscopic ovarian cystectomy versus laparoscopic cyst deroofing on ovarian reserve measured by serum levels of anti mullerian hormone and antral follicle count in patients with endometriomas.

Full description

One of the major concerns about excision of endometriomas is their negative effect on ovarian reserve because of follicle loss, removal of endometriomas has been associated with poorer performance in IVF procedures, and decreased ovarian volumes have also been reported after surgery.Ovarian reserve is defined as the functional potential of the ovary which reflects the number and quality of the follicles left in the ovary, and is well-correlated with the response to ovarian stimulation using exogenous gonadotrophin. Over the years, various tests and markers of ovarian reserve have been reported; the static tests include serum markers, such as basal FSH, inhibin-B and anti-Mullerian hormone (AMH), and ultrasonographic markers, such as ovarian volume and antral follicle count.This study will include 122 patients aged between 18 and 35 years who have been diagnosed with endometrioma (unilateral or bilateral) and they are candidates for laparoscopic surgery. They will be selected according to inclusion and exclusion criteria.they will be randomized into two study groups, one study group will undergo laparoscopic ovarian cystectomy, the other study group will undergo laparoscopic cyst deroofing.AMH,AFC and ovarian volume will be measured pre-operative and post-operative.

Enrollment: 122 patients

Sex: Female

Ages: 18 to 35 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age from 18-35 year
2. Regular menstrual cycles.
3. Endometrioma (unilateral or bilateral) diagnosed by transvaginal ultrasound with diameter ≥ 3 cm.

Exclusion criteria

1. Any previous ovarian surgery.

2. Evidence of polycystic ovary syndrome according to Rotterdam criteria

   -Two of three of:

   • Oligo- or chronic anovulation.
   • Clinical and/or biochemical signs of hyperandrogenism.
   • Polycystic ovaries.

3. Evidence of premature ovarian failure diagnosed by follicle stimulating hormone level ≥40 IU/L

4. Any endocrinal disease affecting ovarian function e.g. thyroid dysfunction, hyperprolactinemia.

5. Previous hormonal medications e.g. oral contraceptive pills, gonadotropin-releasing hormone analogue within the last 3 months before surgery.

6. Any suspicious findings of ovarian malignant diseases diagnosed by transvaginal ultrasound.

7. Contraindication to surgery.

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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122 participants in 2 patient groups

laparoscopic ovarian cystectomy

Active Comparator group

Description:

laparoscopic ovarian cystectomy will be performed on proliferative phase of menstrual cycle.Anti-mullerian hormone level measurement and estimation of antral follicle count will be done before surgery and will be repeated one month after surgery.

Treatment:

Procedure: Laparoscopic ovarian cystectomy

laparoscopic cyst deroofing

Active Comparator group

Description:

laparoscopic cyst deroofing will be performed on proliferative phase of menstrual cycle.Anti-mullerian hormone level measurement and estimation of antral follicle count will be done before surgery and will be repeated one month after surgery.

Treatment:

Procedure: laparoscopic cyst deroofing